Pivotal study to form basis for upcoming biologic license
application to the U.S. FDA

DEERFIELD, Ill.--(BUSINESS WIRE)--Jan 8, 2013 - Baxter
International Inc. (NYSE:BAX) today announced pivotal Phase III
study results evaluating the efficacy and safety of routine
prophylaxis compared to on-demand treatment of FEIBA NF
[Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated,
in patients with hemophilia A or B and inhibitors. Top-line results
from the study showed a reduced median annual bleed rate (ABR) from
28.7 during FEIBA NF on-demand treatment to 7.9 during FEIBA NF
prophylactic treatment (a 72.5% reduction). The Phase III study
will form the basis of a biologics license application (BLA) to be
filed with the U.S. Food and Drug Administration (FDA) in the first
quarter of 2013.

As many as one-third of people with hemophilia develop an
inhibitor to a product used to treat or prevent bleeding episodes.
The presence of an inhibitor makes response to treatment more
challenging and patients with inhibitors have an increased risk of
developing complications such as joint damage.

''Treatment with FEIBA NF resulted in a significant reduction in
annual bleed rate (ABR) of all types of bleeds in the prophylaxis
arm as compared to the on-demand arm,'' said lead investigator, Dr.
Sandra Antunes MD, UNIFESP, Sao Paulo, Brazil. ''Three of the 17
intent to treat patients (17.6 %) in the prophylaxis arm did not
experience any bleeding episodes during the study, and this is very
significant for hemophilia patients with inhibitors.''

The Phase III prospective, open label, randomized, multi-center,
parallel study investigated the efficacy, safety and health-related
quality of life benefits of FEIBA NF prophylactic treatment
compared to on-demand treatment in 36 patients with hemophilia A or
B and inhibitors over a 12-month period. The most commonly reported
adverse reactions in the study were hypersensitivity, dizziness,
headache, rash, hypotension and hepatitis B surface antibody
positive laboratory test result. The occurrence of a transitory
increase in hepatitis B surface antibodies has been seen in certain
plasma-derived products and could be attributed to the passive
transfer of antibodies following FEIBA NF treatment. None of the
subjects showed any signs or symptoms of hepatitis B infection.

This latest study adds to the clinical evidence supporting the
prophylactic use of FEIBA, building on an investigator initiated
study showing that FEIBA can reduce bleeding events in patients
with severe hemophilia A and inhibitors when compared to on-demand
treatment (results published in The New England Journal of
Medicine in November 2011).

''One of the greatest remaining challenges in the management of
hemophilia is the development of inhibitors, which can lead to more
difficult-to-control and sometimes life-threatening bleeding. The
FEIBA NF prophylaxis study demonstrates Baxter's dedication to
providing treatment options to the hemophilia community, including
effective inhibitor management,'' said Prof. Hartmut J. Ehrlich,
M.D., vice president of global research and development in Baxter's
BioScience business.

About FEIBA NF

FEIBA NF is not indicated for prophylaxis use in the United
States. Canada, The Netherlands, Israel, Australia/New Zealand,
Japan and South Korea also do not have a prophylaxis
indication.

Indications for FEIBA NF

In the U.S., FEIBA NF [Anti-Inhibitor Coagulant Complex] is
indicated for the control of spontaneous bleeding episodes or to
cover surgical interventions in hemophilia A and hemophilia B
patients with inhibitors.

Clinical experience suggests that patients with a Factor VIII
inhibitor titer of less than five Bethesda Units (B.U.) may be
successfully treated with Antihemophilic Factor. Patients with
titers ranging between 5 and 10 B.U. may either be treated with
Antihemophilic Factor or FEIBA NF. Cases with Factor VIII inhibitor
titers greater than 10 B.U. have generally been refractory to
treatment with Antihemophilic Factor.

Inadequate response to treatment may result from an abnormal
platelet count or impaired platelet function that were present
before treatment with FEIBA NF, Nanofiltered and Vapor Heated.

Detailed Important Risk Information for FEIBA NF

Thrombotic and thromboembolic events have been reported
during postmarketing surveillance following infusion of FEIBA VH or
FEIBA NF, particularly following the administration of high doses
and/or in patients with thrombotic risk factors.

The use of FEIBA NF is contraindicated:

In patients who have known anaphylactic
or severe hypersensitivity reactions to the product.

In patients who are known to have a
normal coagulation mechanism.

For the treatment of bleeding episodes
resulting from coagulation factor. deficiencies in the absence of
inhibitors to coagulation factor VIII or coagulation factor
IX.

In patients with significant signs of
disseminated intravascular coagulation (DIC).

In patients with acute thrombosis or
embolism (including myocardial infarction).

At first sign or symptoms of an infusion/hypersensitivity
reaction or a thrombotic/thromboembolic event, FEIBA NF
administration should be stopped immediately and diagnostic and
therapeutic measures initiated as appropriate.

Allergic-type hypersensitivity reactions, including severe
anaphylactoid reactions, have been reported following the infusion
of FEIBA. The symptoms include urticaria, angioedema,
gastrointestinal manifestations, bronchospasm, and hypotension;
these reactions can be severe and can be systemic.

Many of the reported cases of thromboembolic events occurred
with doses above 200 units/kg/day or in patients with other risk
factors.

Infusion of FEIBA NF should not exceed single dosage of 100 U/kg
and daily doses of 200 U/kg of body weight. Patients receiving more
than 100 U/kg of FEIBA NF must be monitored for the development of
DIC and/or symptoms of acute coronary ischemia. High doses of FEIBA
NF should be given only as long as absolutely necessary to stop
bleeding.

FEIBA VH or FEIBA NF should be used with particular caution and
only if there are no therapeutic alternatives in patients at risk
of DIC, arterial or venous thrombosis.

Licenses and licensing conditions may vary from country to
country; therefore please always consult your local full
prescribing information. Please check FEIBA NF website for
information on indications approved in other countries.

About Hemophilia A

Hemophilia is a rare genetic blood clotting disorder that
primarily affects males.1 People living with hemophilia
do not have enough of, or are missing, one of the blood clotting
proteins naturally found in blood.1 Two of the most
common forms of hemophilia are A and B.2 In people with
hemophilia A, clotting factor VIII is not present in sufficient
amounts or is absent.2 Without enough FVIII, people with
hemophilia can experience spontaneous, uncontrolled internal
bleeding that is painful, debilitating, damaging to joints and
potentially fatal.2 According to the World Federation of
Hemophilia, more than 400,000 people in the world have
hemophilia.2 All races and economic groups are affected
equally.1

About Hemophilia B

Hemophilia B is the second most common type of hemophilia
(also known as Christmas disease) and is the result of insufficient
amounts of clotting factor IX, a naturally occurring protein in
blood that controls bleeding.3 Approximately 25,000
people worldwide, including more than 4,000 in the U.S., have been
diagnosed with hemophilia B. 4 Hemophilia B is often a
debilitating, chronic disease with complications that include
bleeding episodes, hemophilic arthropathy (bleeding into a joint)
and hospitalization.5

About Inhibitors

As many as one-third of patients with severe or moderately
severe hemophilia A are at risk for developing inhibitors, which
are antibodies produced by the body's immune system in response to
factor replacement therapy. Inhibitors cause the body to work
against the factor replacement therapy, neutralizing its effect and
preventing an individual's blood from appropriate
clotting.6 Individuals who have inhibitors have a form
of hemophilia that is more difficult to control, with an increased
risk of uncontrolled bleeding, compared to patients without
inhibitors. Inhibitor development is considered one of the most
serious complications associated with hemophilia treatment, and may
include other associated complications such as impaired movement,
increased need for surgery and greater complexity or risk
associated with surgery, lower life expectancy and poor
health-related quality of life. 6,7

About Baxter in Hemophilia

Baxter has more than 60 years experience in hemophilia and has
introduced a number of therapeutic firsts for hemophilia patients.
Baxter has the broadest portfolio of hemophilia treatments in the
industry and is able to meet individual therapy choices, providing
a range of options at each treatment stage. The company's work is
focused on optimizing hemophilia care and improving the lives of
people living with hemophilia A and B worldwide.

About Baxter International Inc.

Baxter International Inc., through its subsidiaries, develops,
manufactures and markets products that save and sustain the lives
of people with hemophilia, immune disorders, cancer, infectious
diseases, kidney disease, trauma and other chronic and acute
medical conditions. As a global, diversified healthcare company,
Baxter applies a unique combination of expertise in medical
devices, pharmaceuticals and biotechnology to create products that
advance patient care worldwide.

This release includes forward-looking statements concerning
the company's Phase III study evaluating the efficacy and safety of
routine prophylaxis compared to on-demand treatment of FEIBA NF in
hemophilia patients with inhibitors, including expectations
regarding related regulatory filings. The statements are based
on assumptions about many important factors, including the
following, which could cause actual results to differ materially
from those in the forward-looking statements: satisfaction of
regulatory and other requirements; actions of regulatory bodies and
other governmental authorities; changes in laws and regulations;
product quality or patient safety issues; and other risks
identified in Baxter's most recent filing on Form 10-K and other
SEC filings, all of which are available on Baxter's website. Baxter
does not undertake to update its forward-looking
statements.